MAUDE Adverse Event Report: BIOMET 3I BELLATEK HYBRID BAR 4 IMPLANTS; DENTAL IMPLANT BAR

Catalog Number	CSHY04
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).B3: date of event unknown / not provided.E1: last/given name unknown / not provided.G4: additional pma/510(k) number ¿ k241032.Customer has indicated that the product is in process of being returned to zimvie for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the bar broke in patient's mouth.Will be returning the broken one and remaking a new bar.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.D9: device availability and return date were updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were added: 4111 and 3331.H6: investigation findings code was added: 3252.H6: investigation conclusions code was added: 4307.H10: narrative/data was updated.Zimvie received the reported bar for evaluation.Visual evaluation was performed.The returned bar/prosthesis was fractured.Dhr review was completed for the subject lot number.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.A lot specific complaint history review is not conducted for psp complaints.Patient specific products have a unique one time use lot number.Therefore, a lot specific history search for the bar was not performed.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was patient factors.Therefore, based on the available information, device malfunction has occurred.The returned bar was observed to be fractured.The reported event has been confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: BELLATEK HYBRID BAR 4 IMPLANTS
• Common Device Name: DENTAL IMPLANT BAR
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 21021203
• Report Number: 0001038806-2024-03007
• Device Sequence Number: 14445285
• Product Code: NHA
• UDI-Device Identifier: 00844868001676
• UDI-Public: (01)00844868001676(17)320427(10)8724950-1
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K080864
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: CSHY04
• Device Lot Number: 8724950-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic